by Stephanie Barnes, Editor, Foods Team Member “Over the years FDLI and FDA have enjoyed a very rich history together; of course we share a set of interests at the nexus of food, drug ...read more
by Benny Spiewak Early in March 2012, the Brazilian Government announced the incorporation of BioBrasil, the Government-supported super pharmaceutical Brazilian company, which is formed by f...read more
by David Restaino, Esq. On December 30, 2011, the Food & Drug Administration (FDA) released a draft guidance document entitled Responding to Unsolicited Requests for Off-Label Informatio...read more
by Jennifer Bragg, Michael Loucks and Erin Hayes Assume for the moment that those within your company who are tasked with business development are pushing expansion into Brazil. As the seven...read more
by Paul Greenberg and Tammy Sisitsky The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) are both central to the process by which dru...read more
James M. Solyst of ENVIRON International Corporation makes the argument that, at a time when federal budgets are precarious, the private sector must be prepared to continue to contribute to the sci...read more
by Jamie Kendall and Noah Mallon The authors assert that FDA’s vagueness in the December 27, 2011-released Draft Guidance for Responding to Unsolicited Requests for Off-Label Information (&l...read more
On February 13, 2012, FDLI hosted a one-day program where officials from the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ) and expe...read more
In the absence of comprehensive chemical management reform at the federal level, many states have begun enacting laws to minimize or eliminate the generation, use, and disposal of certain chemicals...read more
The current stance of the U.S. Food and Drug Administration (FDA) is that, while the agency sees the results of some novel studies as providing “a reason for some concern about the potential ...read more